Controlling Orthostatic Hypotension in People With Cervical Spinal Cord Injury
Keywords
Abstract
Description
Participants will engage in three initial heads-up tilt table sessions with no FES intervention to confirm the presence and consistency of OH. During these sessions, the participant will lie supine on a tilt table at 0°, and, using a blood pressure cuff secured around the arm, the researchers will measure and record supine blood pressure. The researchers will then adjust the tilt table to 30° for three minutes and take and record another blood pressure measurement. If the participant reports no OH symptoms and the researchers observe no changes in appearance or signs of distress at that time, the researchers will query the participant about willingness to adjust the table to an additional 10° of tilt. Following three minutes at this level, the researchers will again measure and record the participant's blood pressure. These procedures will continue with increments of 10° of increased tilt every three minutes to a maximum of 90° tilt until the session time (maximum of 60 minutes) has elapsed or the participant expresses discomfort, measured blood pressure drops relative to the supine recording, or the researchers observe behaviors indicative of OH (e.g., sweating, change in skin color, change in breathing pattern, grimacing). If any of these OH symptoms occur, the researchers will adjust the tilt table to lower levels of incline until the participant's blood pressure stabilizes to the supine position measurement, and the session will be terminated.
Intervention sessions will begin after three days of baseline measurements. Intervention sessions will follow the same procedures except that the conditions will alternate randomly among the three FES placement and the no FES conditions. All sessions will be held at Quality Living, Inc., in Omaha, Nebraska.
Dates
| Last Verified: | 03/31/2020 |
| First Submitted: | 04/22/2020 |
| Estimated Enrollment Submitted: | 04/26/2020 |
| First Posted: | 04/29/2020 |
| Last Update Submitted: | 04/26/2020 |
| Last Update Posted: | 04/29/2020 |
| Actual Study Start Date: | 04/22/2020 |
| Estimated Primary Completion Date: | 04/29/2022 |
| Estimated Study Completion Date: | 04/29/2022 |
Condition or disease
Intervention/treatment
Device: Intervention
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Experimental: Intervention All participants will receive intervention in four conditions: (a) no FES, (b) calves only FES, (c) quads and abdominals only FES, and (d) calves, quads, and abdominals FES. Session-by-session alternation among conditions will occur in a unique, predetermined, randomized order for each participant. | Device: Intervention Randomized placement of FES pads in one of four locations during each session. Locations include: (a) none, (b) calves only, (c) quads and abdominals only, and (d) calves, quads, and abdominals. |
Eligibility Criteria
| Ages Eligible for Study | 19 Years To 19 Years |
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | Yes |
| Criteria | Inclusion Criteria: - adult resident of Quality Living, Inc. - SCI at the level of C5 or higher - experience OH upon rising from a sitting or supine position - comprehend English sufficiently to understand the consent form as measured by responses to included questions Exclusion Criteria: - any person who has a legally authorized representative responsible for making healthcare decisions because of compromised cognitive or communication status - any person for whom FES is contraindicated as determined by the physiatrist responsible for monitoring the health and rehabilitation programs of Quality Living residents |
Outcome
Primary Outcome Measures
1. Change in tilt table angle from 0 degrees to maximum tolerated during session [Measured over the course of each one hour tilt table session]
2. Change in blood pressure from initial reading at start of each tilt table session [Measured every three minutes throughout the time a participant is positioned on the tilt table]
